Electrophysiological Effects of Irbesartan in Patients With Paroxysmal Atrial Fibrillation (AF)

Condition(s) targeted: Atrial Fibrillation

Intervention: Irbesartan (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Bristol-Myers Squibb

Official(s) and/or principal investigator(s):
Miguel Angel Sanchez Zamorano, MD, Study Director, Affiliation: Medical Department, Bristol-Myers Squibb

The main purpose of the study is to compare the mean AERP between treatment groups based on the hypothesis that in subjects with paroxysmal AF, Irbesartan prevents electrophysiological remodeling resulting in a prolonged atrial effective refractory period relative (AERP) to placebo.

Official title: Electrophysiological Effects of Irbesartan in Patients With Paroxysmal Atrial Fibrillation (AF)

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

Primary outcome: Irbesartan effect on duration of Atrial Effective Refractory Period (AERP) in paroxysmal AF (PAF) patients.

Secondary outcome:

Irbesartan effect on A Function RP

Irbesartan effect on atrial conduction intervals after basal & extra-stimuli, in PAF patients

Refractoriness dispersion

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Recurrent PAF with indication for catheter ablation

Exclusion Criteria:

- Struct. Cardiopathy

- Mitral valve disease

- VEF<40%

- Myocardiopathy

- LVH

- cardiac surgery

- AF reversible

- QT c>450

- Recent MI/stroke, severe HTN

- Requirement of ACEI/ARBs

- Coronary synd., HTA, liver disease

Local Institution, Madrid 28905, Spain

Local Institution, Madrid 28046, Spain

Local Institution, Madrid 28040, Spain

BMS Clinical Trials Disclosure

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm

Starting date: July 2006
Ending date: June 2007
Last updated: June 2, 2008